Luminastil

Before using Luminastil, carefully read the leaflet and fill out

Patient Information.

The medicine is intended only for adult patients.

Leaflet attached to the packaging: information for the patient

Luminastil, 50 mg, tablets

Diphenhydramine hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Luminastil and what is it used for
• 2. Important information before taking Luminastil
• 3. How to take Luminastil
• 4. Possible side effects
• 5. How to store Luminastil
• 6. Contents of the pack and other information

1. What is Luminastil and what is it used for

Luminastil is a medicine that contains the active substance diphenhydramine hydrochloride. Diphenhydramine belongs to a group of antihistamines with sedative and calming effects.

Indications for use

Short-term use in occasional insomnia in adults. Occasional insomnia may occur especially when there are difficulties falling asleep, frequent nighttime awakenings, early morning awakenings related to stress or time zone changes. Sleep disorders can negatively affect physiological processes and lead to a decrease in psychophysical fitness. We talk about insomnia, among other things, when: the time to fall asleep exceeds half an hour, the total time spent awake at night lasts longer than half an hour, such disruption occurs at least three nights a week, and poor sleep quality causes fatigue or reduced psychophysical fitness during the day. Transient sleep disorders can be caused by various factors, such as stress, illness, anxiety, personal or work-related problems, or fatigue related to time zone changes. Diphenhydramine contained in Luminastil causes a shortening of the time to fall asleep and increases the depth and quality of sleep. Taking medication is not the primary method of treating sleep disorders and should be limited to short-term use only. Prolonged poor sleep quality may be a symptom of psychological and physical disorders that require other treatment methods, which should be assessed by a doctor. Consulting a doctor is also necessary in case of symptoms other than insomnia.

The medicine should not be used to treat chronic sleep disorders.

The treatment period should be as short as possible. The medicine should not be used for more than 7 days without consulting a doctor.If after 7 days there is no improvement or you feel worse, you should consult your doctor.

2. Important information before taking Luminastil

When not to take Luminastil

• if you are allergic to diphenhydramine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have a gastric or duodenal ulcer (damage to the mucous membrane of the stomach or initial section of the intestine);
• if you have gastric or intestinal obstruction (caused by an ulcer, etc.);
• if you have a pheochromocytoma (a tumor of the adrenal gland);
• if you have heart problems called QT interval prolongation;
• if you have cardiovascular disease or low blood pressure;
• if you have low levels of electrolytes in the blood (e.g., decreased potassium or magnesium levels);
• if you are taking medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see section: "Luminastil and other medicines");
• if there has been a sudden death in your family due to heart disease.

Warnings and precautions

Before starting to use Luminastil, you should discuss it with your doctor or pharmacist:

• if you have myasthenia gravis (a disease characterized by excessive muscle weakness);
• if you have epilepsy or seizure disorders;
• if you have glaucoma with a closed angle of filtration (an eye disease related to increased pressure in the eye);
• if you have an enlarged prostate or difficulty urinating (urinary retention);
• if you have asthma, bronchitis, or chronic obstructive pulmonary disease (COPD);
• if you have moderate or severe liver or kidney function disorders;
• if you are elderly (over 65 years old), as there is a greater likelihood of side effects.

You should stop taking this medicine if you experience any symptoms or signs of heart rhythm disorders. In such a case, you should immediately contact your doctor. In case of persistent insomnia, you should contact your doctor, as insomnia may be a symptom of a serious underlying disease.There have been reports of abuse and dependence on diphenhydramine in young adults and (or) in patients with mental disorders and (or) in those who have previously had substance abuse disorders. Any signs of dependence or abuse of the medicine should be reported to the doctor immediately. Diphenhydramine should be used for the shortest possible period. Luminastil may be less effective if taken continuously. Taking the medicine may lead to the development of tolerance and (or) dependence. If after 7 days of taking the medicine you do not feel better or feel worse, you should definitely contact your doctor.

Allergy tests

The medicine may affect the results of allergy tests; you should not take the medicine at least 3 days before undergoing these tests.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Luminastil and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The medicine may enhance the effect of certain medicines.

You should not take Luminastil if you are taking medications used to treat heart rhythm disorders or medications that may affect heart rhythm.

You should not take Luminastil with other antihistamines, including those used on the skin or those used to treat coughs and colds. You should inform your doctor if you are taking any of the following medicines:

• sedatives, sleeping pills, and anxiolytics, as diphenhydramine may enhance their sedative effect;
• monoamine oxidase inhibitors (MAOIs - medicines used to treat depression), as they may prolong and enhance the effect of diphenhydramine. Luminastil should be used with caution with MAOIs and within 2 weeks after their withdrawal;
• tricyclic antidepressants (used to treat depression, such as amitriptyline, doxepin), as diphenhydramine may enhance their effect;
• venlafaxine (a medicine used to treat depression);
• atropine (a medicine used to dilate the pupils);
• metoprolol (a medicine used to treat high blood pressure, heart problems, and to prevent migraines).

Luminastil with alcohol

You should not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine. You should not use Luminastil during pregnancy and breastfeeding.

Driving and using machines

Luminastil is a sedative medicine that will soon cause drowsiness and sedation after taking a dose. You should not drive vehicles or operate machines for at least 8 hours after taking the last dose of Luminastil. The medicine may also cause dizziness, blurred vision, attention disorders, psychomotor disorders, and weakened reactions. If you experience such symptoms, you should not drive vehicles or operate machines.

The medicine contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Luminastil

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. The medicine is for oral use.

Recommended dose

Adults

If necessary, 1 tablet 20 minutes before bedtime. You should not exceed the recommended dose and frequency of administration. You should not exceed the maximum daily dose of the medicine: 1 tablet per day. You should not take an additional tablet after waking up at night.

Duration of treatment

Treatment should be as short as possible. The medicine should not be used for more than 7 days without consulting a doctor. If after 7 days there is no improvement or you feel worse, you should consult your doctor.

Use in children and adolescents

Luminastil should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Luminastil than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately consult your doctor or the nearest Emergency Department. Overdose may cause: dilated pupils, fever, facial flushing, excitement, muscle tremors, involuntary movements, hallucinations (perception of non-existent objects or people), and changes in the ECG recording. Significant overdose of the medicine may cause rhabdomyolysis (muscle breakdown), seizures, delirium, toxic psychosis, heart problems, coma, and cardiovascular collapse.

Missing a dose of Luminastil

You should not take a double dose to make up for a missed dose. You should take the next dose the next day as recommended in the leaflet. If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Luminastil and immediately contact your doctor or go to the Emergency Department of the nearest hospital if you experience any of the following side effects:

• angioedema (severe allergic reaction - sudden swelling of the lips, tongue, throat, face, limbs, or joints without itching and pain). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• rash (itchy, red bumps on the skin);
• urticaria (light red, itchy blisters on the skin);
• shortness of breath. The frequency of these symptoms is unknown.

Other side effects

Common(occurring in 1 to 10 people out of 100):

• fatigue, sedation;
• drowsiness;
• attention disorders;
• difficulty maintaining balance, dizziness;
• dry mouth.

Frequency not known(cannot be estimated from available data):

• gastrointestinal disorders, including nausea, vomiting;
• disorientation, paradoxical excitement (e.g., increased energy, restlessness, nervousness);
• seizures, headaches;
• paresthesia (tingling, numbness, or changes in skin temperature);
• dyskinesia (uncoordinated and involuntary movements of the limbs or the whole body, bending and stretching, involuntary movements of the lips, tongue protrusion);
• blurred vision;
• tachycardia (rapid heartbeat), palpitations (irregular, rapid heartbeat);
• thickening of bronchial secretions (phlegm);
• muscle tremors;
• difficulty urinating, urinary retention.

Elderly people (over 65 years old) are more prone to disorientation and paradoxical excitement.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Luminastil

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C, in the original packaging. Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Luminastil contains

• The active substance of the medicine is diphenhydramine hydrochloride. Each tablet contains 50 mg of diphenhydramine hydrochloride.
• Other ingredients are: lactose monohydrate, microcrystalline cellulose, corn starch, colloidal anhydrous silica, magnesium stearate.

What Luminastil looks like and what the pack contains

Luminastil is in the form of tablets. The tablets are oblong, oval, biconvex, white, without spots and damage. The pack contains 10 tablets, packaged in blisters of aluminum/PVDC/PVC white, orange, or colorless, in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel.: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o., ul. Szkolna 31, 95-054 Ksawerów, Date of last update of the leaflet:06.2024